Principal Investigators:
Mervin Gotsman MD, Ludmilla Lapidus MD, Yelena Novikov MD, A. Teddy Weiss MD, David Leibowitz MD

Sponsor:
Bayer, Germany

Monitor:
Pharma Clinical

Abstract:

ACTION is a multi-national, multi-center, randomized, double-blind, placebo-controlled clinical trial with two parallel treatment arms of equal size in at least 6000 patients.
Consenting ambulatory patients with chronic symptomatic coronary artery disease (angina pectoris) aged at least 35 years will be screened for inclusion at the out-patient clinic (Europe, Canada, Israel, Australia). No major clinical events may have occurred within three months before start of study medication. The patient must be in stable clinical condition, require anti-anginal medication and be free from clinically significant heart failure. The left-ventricular ejection fracture must be documented by 2-D-echocardiogram, and must be at least 40%. In patients who are treated already with a calcium-antagonist, this must have stopped at least two weeks before start of the study medication.
The primary criterion for the evaluation of efficacy will be the combined rate of: death, acute myocardial infarction, emergency coronary angiography for refractory angina, overt heart failure, debilitating stroke and peripheral revascularisation. The two treatment arms will be compared by assigned treatment. The primary analysis will be a conventional intention-to-treat analysis, focusing on all patients who have been randomized.

Status
Ongoing trial